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FDA 510(k) Application Details - K180607
Device Classification Name
More FDA Info for this Device
510(K) Number
K180607
Device Name
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
Applicant
KRONUS, Inc.
170 S. Seneca Springs Way
Suite 105
Star, ID 83669 US
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Contact
Brian Deis
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Regulation Number
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Classification Product Code
PCG
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Date Received
03/07/2018
Decision Date
11/23/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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